Senator Tammy Baldwin (D-WI) sent letters on January 29 to companies warning of improper Orange Book listings of patents for inhalers, following up on the FTC’s focus on potential anticompetitive harm of improper listings.
Companies Receive FTC Notices Alleging Improper Orange Book Listings
On November 7, 2023, the Federal Trade Commission (“FTC”) announced that it had issued notice letters to 10 life sciences companies regarding 100 patents that the FTC contends are improperly listed in the Orange Book, the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations.
Read the full post on the Duane Morris Life Sciences Law Blog.
FTC Warns Drug Companies About Improper Listings of Patents in Orange Book
On Thursday September 14, 2023, the FTC issued a policy statement warning brand drug companies that improper listing of patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book” could violate Section 5 of the FTC Act.